US5749203AExpiredUtility

Method of packaging a medical article

80
Assignee: KIMBERLY CLARK COPriority: Sep 23, 1994Filed: Sep 23, 1994Granted: May 12, 1998
Est. expirySep 23, 2014(expired)· nominal 20-yr term from priority
Inventors:James Mcgowan,
B65B 55/18B65B 31/028B65B 31/043B65B 31/04
80
PatentIndex Score
59
Cited by
71
References
42
Claims

Abstract

A method for sterilizing an article supported in a housing is provided. The method includes placing an article in a housing, introducing pressurized steam and a sterilizing gas into the housing and closing the housing. The sterilizing gas may be mixture of ethylene oxide/carbon dioxide or ethylene oxide/nitrogen. The percent by volume of ethylene oxide in the housing at the conclusion of the sterilizing gas introducing step may range from at least about 2% to about 25% by volume. The present invention is particularly well suited for use with a form-fill-seal process.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method of packing an article comprising: placing the article in a housing;   evacuating at least some of the gases in the housing;   introducing steam and a sterilizing gas into the evacuated housing; and   closing the housing, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       2. The method of claim 1 further including the step of partially closing the housing prior to the introducing step. 
     
     
       3. The method of claim 1 wherein the sterilizing gas is a mixture of ethylene oxide and a carrier gas. 
     
     
       4. The method of claim 3 wherein the percent by volume of ethylene oxide in the housing at the conclusion of the introducing step is at least about 2%. 
     
     
       5. The method of claim 1 wherein the steam and the sterilizing gas are introduced simultaneously into the housing. 
     
     
       6. The method of claim 1 wherein the pressure of the steam at the point of introduction into the housing is between about 15 psi to about 80 psi. 
     
     
       7. The method of claim 1 further including the step of heating the closed housing to between about 120° Fahrenheit to about 140° Fahrenheit for at least about four hours. 
     
     
       8. A method of packing an article comprising: placing the article in a housing;   partially closing the housing;   providing a gas conduit for accessing gases within the housing;   evacuating, through the gas conduit, at least some of the gases within the housing;   introducing, through the gas conduit, steam and a sterilizing gas into the evacuated housing;   removing the gas conduit from the housing; and   closing the housing, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       9. The method of claim 8 wherein the article is a nonwoven article. 
     
     
       10. The method of claim 8 wherein the pressure within the housing at the conclusion of the evacuating step is between about 30 to about 100 millibars of mercury. 
     
     
       11. The method of claim 8 wherein the steam and the sterilizing gas are simultaneously introduced into the housing. 
     
     
       12. The method of claim 8 wherein the sterilizing gas is a gaseous mixture of ethylene oxide and at least one carrier gas. 
     
     
       13. The method of claim 12 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is at least about 2%. 
     
     
       14. A method of sterilizing an article comprising: placing the article into a formed bottom web;   forming a housing by overlying the formed bottom web with a top web;   partially closing the housing;   positioning a gas nozzle within the housing;   evacuating, through the gas nozzle, at least some of the gases within the housing;   introducing, through the gas nozzle, steam and a sterilizing gas into the evacuated housing;   removing the gas nozzle and closing the housing; and   heating the closed housing to between about 120° Fahrenheit to about 140° Fahrenheit for at least about four hours, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       15. The method of claim 14 wherein steam and the sterilizing gas are introduced simultaneously. 
     
     
       16. The method of claim 14 wherein the sterilizing gas is a mixture of ethylene oxide and a carrier gas, wherein the carrier gas is selected from the group consisting of carbon dioxide and nitrogen. 
     
     
       17. The method of claim 16 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is at least about 2%. 
     
     
       18. The method of claim 16 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is between about 4% to about 10%. 
     
     
       19. A method of packing an article comprising: placing the article in a housing;   partially closing the housing containing the article;   providing a gas conduit for accessing gases within the housing containing the article;   evacuating, through the gas conduit, at least some of the gases within the housing containing the article;   introducing, through the gas conduit, steam and a sterilizing gas into the evacuated housing; and   closing the sterilizing gas containing housing, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       20. The method of claim 19 wherein the article is a nonwoven article. 
     
     
       21. The method of claim 19 wherein the pressure within the housing at the conclusion of the evacuating step is between about 30 to about 100 millibars of mercury. 
     
     
       22. The method of claim 19 wherein the steam and the sterilizing gas are simultaneously introduced into the housing. 
     
     
       23. The method of claim 19 wherein the sterilizing gas is a gaseous mixture of ethylene oxide and at least one carrier gas. 
     
     
       24. The method of claim 23 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is at least about 2%. 
     
     
       25. A method of sterilizing an article comprising: placing the article into a formed bottom web;   forming a housing by overlying the formed bottom web containing the article with a top web;   partially closing the housing containing the article;   positioning a gas nozzle within the housing containing the article;   evacuating, through the gas nozzle, at least some of the gases within the housing containing the article;   introducing, through the gas nozzle, steam and a sterilizing gas into the evacuated housing;   removing the gas nozzle and closing the sterilizing gas containing housing; and   heating the closed housing containing the sterilizing gas, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       26. The method of claim 25 wherein steam and the sterilizing gas are introduced simultaneously. 
     
     
       27. The method of claim 25 wherein the sterilizing gas is a mixture of ethylene oxide and a carrier gas, wherein the carrier gas is a member selected from the group consisting of carbon dioxide and nitrogen. 
     
     
       28. The method of claim 27 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is at least about 2%. 
     
     
       29. The method of claim 27 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is between about 4% to about 10%. 
     
     
       30. The method of claim 25 wherein the housing is heated to between about 120° Fahrenheit to about 140° Fahrenheit for at least about four hours. 
     
     
       31. The method of claim 27 wherein the percent, by volume, of ethylene oxide present in the housing at the conclusion of the introducing step is at least about 4%. 
     
     
       32. A method of sterilizing an article comprising: placing the article into a formed bottom web;   forming a housing by overlying the formed bottom web containing the article with a top web;   partially closing the housing containing the article;   positioning a gas nozzle within the housing containing the article;   evacuating, through the gas nozzle, at least some of the gases within the housing containing the article, wherein the pressure within the housing at the conclusion of the evacuation step is between about 30 to about 100 millibars of mercury;   introducing, through the gas nozzle, steam and a sterilizing gas into the evacuated housing, wherein the pressure within the housing at the conclusion of the introducing step is between 300 and 700 millibars of mercury and wherein the percent, by volume, of sterilizing gas present in the housing is at least 4%;   removing the gas nozzle and closing the sterilizing gas containing housing; and   heating the closed housing containing the sterilizing gas to between about 120° Fahrenheit to about 140° Fahrenheit for at least about four hours, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       33. A method of packing an article comprising: placing the article in a housing;   evacuating at least some of the gases in the housing;   introducing steam into the evacuated housing;   introducing a sterilizing gas into the evacuated housing to effect sterilization of the article; and   closing the housing, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 10% or less by volume of the housing.     
     
     
       34. The method of claim 1 wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 8% by volume or less. 
     
     
       35. The method of claim 8 wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 8% by volume or less. 
     
     
       36. The method of claim 33 wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 8% by volume or less. 
     
     
       37. The method of claim 14 wherein the article is sterilized in 18 hours or less. 
     
     
       38. The method of claim 25 wherein the article is sterilized in 18 hours or less. 
     
     
       39. The method of claim 32 wherein the article is sterilized in 18 hours or less. 
     
     
       40. A method of packing an article comprising: placing the article in a housing;   evacuating at least some of the gases in the housing;   introducing steam and a sterilizing gas into the evacuated housing; and   closing the housing, wherein the concentration of sterilizing gas at the conclusion of the introducing step is about 20% or less by volume of the housing.     
     
     
       41. The method of claim 40 wherein the concentration of sterilizing gas is about 15% or less by volume of the housing. 
     
     
       42. The method of claim 40 wherein the concentration of sterilizing gas is about 5% or less by volume of the housing.

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